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Latest From Sangamo Therapeutics, Inc.

First EMA Nod For Generic Xarelto; Apotex Pulls Upkanz For Neurodegenerative Disease

While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.

Drug Review Europe

Sanofi Seeks Double Vaccine Approval Nod In EU

The sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.

Drug Review Europe

Roctavian’s Durability: For The Price, Payers Wanted Longer-Term Proof Anyway

FDA’s decision to seek two more years of data for BioMarin’s gene therapy for hemophilia A ‘makes perfect sense,’ Harvard Pilgrim Health Care’s Michael Sherman says.

Reimbursement Gene Therapy

Not Such A Sure Thing: FDA Knocks Back BioMarin’s Roctavian

BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.

Complete Response Letters Gene Therapy
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
    • Drug Discovery Tools
      • Genomics-Proteomics
  • Other Names / Subsidiaries
    • Ceregene, Inc
    • Sangamo Biosciences, Inc.
    • TxCell S.A.
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